Z-0986-2011

KING LT -D Laryngeal Tube, Size 4, KLTD204, King Systems Corporation 15011 Herriman Boulevard, Noblesville...

Name: Z-0986-2011 KING LT -D Laryngeal Tube, Size 4, KLTD204, King Systems Corporation 15011 Herriman Boulevard, Noblesville...
Creator: King Systems Corp.
Published: 2009-12-15
License: https://open.fda.gov/license/

King Systems Corporation. / initiated 2009-12-15 / Terminated / root cause: labeling and UDI

FDA source

King Systems Corp. began a recall of KING LT -D Laryngeal Tube, Size 4, KLTD204, King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by... on 2009-12-15. The reason FDA records is "King Systems was issued a warning letter from the Center for Devices and Radiological Health, Office of Compliance on October 28, 2009. The warning letter asserts that Kings Systems KLT(S)-D airway exceeds cleared...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0986-2011
Status: Terminated
Initiated: 2009-12-15
Posted: 2011-01-27
Terminated: 2012-08-16
Recalling firm: King Systems Corporation.
Product: KING LT -D Laryngeal Tube, Size 4, KLTD204, King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.
Product code: CAE Airway, Oropharyngeal, Anesthesiology
Reason for recall: King Systems was issued a warning letter from the Center for Devices and Radiological Health, Office of Compliance on October 28, 2009. The warning letter asserts that Kings Systems KLT(S)-D airway exceeds cleared indications in that it is promoted for "airway management in patients over 4 feet in height, for controlled or spontaneous ventilation, difficult and emergent airway cases, and ambulat
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: On October 29, 2009, the firm, Kings System, sent a "Urgent - Product Correction" letter to the customers. The letter described the product, problem and actions to be taken. The customers were instructed to remove the promotional material from the King System website which includes literature, and Instructions for Use. The firm instructed all Sales force and distributors to cease dissemination of promotional materials, literature and communications. Note: The firm revised indications, instructions for use, product labels and labeling so it is aligned with the 510Ks. The customers were also instructed to replace current instructions for use with revised instructions for use and destroy the current IFU; return Kings LT(S)-D oropharyngeal airway product inventory to King Systems; and complete and return the attached Instructions for Use Destruction Signature Form via fax to King Systems at 317-776-5197. For further information, please call 317-776-6823 ext 257 or email: [email protected].
Distribution: Worldwide distribution: USA and countries including: Canada, Costa Rica, and Panama.
Product codes and lots: all product produced prior to 12/09.

Product code CAE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)